MAUDE Adverse Event Report: WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE; GUIDE, SURGICAL, INSTRUMENT

Model Number	312.20
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Complainant part is not expected to be returned for manufacturer review/investigation.Product was not returned.Based on the information available, it has been determined that no corrective and preventative action is proposed.This complaint will be accounted for and monitored via post market surveillance activities.If additional information is made available, the investigation will be updated as applicable.A device history record (dhr) review was conducted: part: 312.200, lot: 2043423.Manufacturing site: bettlach release to warehouse date: 22.October 2002.A manufacturing record evaluation was performed for the finished device lot number, and no non-conformances were identified.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that on (b)(6) 2020, the patient underwent an unknown procedure.During the procedure, the triple drill guide hole was noticed to be damage.The damage was done prior to the case.The wire would not pass through one of the guides.The triple drill guide was replaced and the procedure was successfully completed with no surgical delay.There was no patient consequence.Concomitant device reported: unknown wire (part#: unknown, lot#: unknown, quantity: 1).This report is for one (1) 2.0mm parallel drill guide and drill sleeve.This is report 1 of 1 for (b)(4).

• Brand Name: 2.0MM PARALLEL DRILL GUIDE AND DRILL SLEEVE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): WRIGHTS LANE SYNTHES USA PRODUCTS LLC; 1302 wrights lane east; west chester PA 19380
• MDR Report Key: 10979383
• Report Number: 2939274-2020-05526
• Device Sequence Number: 16361605
• Product Code: FZX
• UDI-Device Identifier: 10886982187673
• UDI-Public: (01)10886982187673
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 312.20
• Device Catalogue Number: 312.200
• Device Lot Number: 2043423
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/12/2020
• Initial Report FDA Received Date: 12/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 68